(294 days)
Not Found
No
The summary describes a chemical reagent kit and associated calibrators and controls for a standard laboratory analyzer. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance data presented is based on traditional analytical methods like precision and method comparison.
No
This device is an in vitro diagnostic (IVD) product used for the quantitative determination of glucose to aid in the diagnosis and treatment of carbohydrate metabolism disorders, not to directly treat a medical condition.
Yes
This device, ELITech Clinical Systems GLUCOSE PAP SL, is intended for "quantitative in vitro diagnostic determination of glucose" and its measurements are "used in the diagnosis and treatment of carbohydrate metabolism disorders." These phrases explicitly state its purpose as a diagnostic tool.
No
The device description clearly states it is a kit consisting of reagents and lyophilized human serum products, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the ELITech Clinical Systems GLUCOSE PAP SL is intended for "quantitative in vitro diagnostic determination of glucose in human serum and plasma." It also mentions its use in the "diagnosis and treatment of carbohydrate metabolism disorders." The calibrators and controls are also described as being for "in vitro diagnostic use."
- Device Description: The description details reagents, calibrators, and control serums used to perform the diagnostic test on human samples (serum and plasma).
- Performance Studies: The document mentions performance data presented in comparison tables to predicate devices, which is typical for IVD submissions.
- Key Metrics: The listed key metrics (Precision, Method comparison, Measuring range, Detection, Limitations) are all relevant to the performance evaluation of an IVD.
The entire context of the document points to the device being used to perform a diagnostic test on biological samples outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ELITech Clinical Systems GLUCOSE PAP SL is intended for use with ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II on Vital Scientific Selectra/Flexor analyzers for the quantitative in vitro diagnostic determination of glucose in human serum and plasma. It is not intended for use in Point of Care settings.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.
Product codes (comma separated list FDA assigned to the subject device)
CGA, JIX, JJX
Device Description
ELITech Clinical Systems GLUCOSE PAP SL: The device for this submission is available as kit only. It consists of 1 reagent, "R." Reagent R consists of Phosphate buffer (pH 7.4), Phenol, 4-Aminoantipyrine (4-AAP), Glucose oxidase (Aspergillus sp.), Peroxidase (horseradish) and sodium azide.
ELITech Clinical Systems ELICAL 2: ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II: ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
K/oos25
DEC 1 5 2010 SECTION 5 - 510(k) Summary ELITech Clinical Systems GLUCOSE PAP SL reagent According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. The assioned 510(k) number is: K100525 Submitter SEPPIM S.A.S. Zone Industrielle, 61500 SEES, FRANCE Address Phone number + 33 (0)2 33 81 21 00 Fax number + 33 (0)2 33 28 77 51 Contact Valérie GOURDON (Email: v.gourdon@elitechgroup.com) Monday, February 15th 2010 Date of Preparation Device names REAGENT : Trade/proprietary Name: ELITech Clinical Systems GLUCOSE PAP SL Common or Usual Name: Glucose, "GLUCOSE PAP SL" Device Class Class II Classification name Glucose test system (Sec.862.1345) Product code CGA - Glucose Oxidase, Glucose ABX PENTRA GLUCOSE PAP CP (K052007) Predicate device The device for this submission is available as kit only. It consists of 1 Device description reagent, "R." Reagent R consists of Phosphate buffer (pH 7.4), Phenol, 4-Aminoantipyrine (4-AAP), Glucose oxidase (Aspergillus sp.), Peroxidase (horseradish) and sodium azide. ELITech Clinical Systems GLUCOSE PAP SL is intended for use with Intended Use ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELI-TROL I and ELITROL II on Vital Scientific Selectra/Flexor analyzers for the quantitative in vitro diagnostic determination of glucose in human serum and plasma. It is not intended for use in Point of Care settings. ELITech Clinical Systems GLUCOSE PAP SL is intended to measure Indication(s) for Use
- glucose in human serum and plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma
1
Comparison to Predicate device
| | ELITech Clinical Systems Device
GLUCOSE PAP SL | Predicate device
(ABX PENTRA GLUCOSE PAP CP) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Intended for use with ELITech
Clinical Systems ELICAL 2 and
ELITech Clinical Systems ELI-
TROL I and ELITROL II on Vital
Scientific Selectra/Flexor analyz-
ers for the quantitative in vitro
diagnostic determination of glu-
cose in human serum and plas-
ma. It is not intended for use in
Point of Care settings. | For in vitro diagnostic use in the
quantitative determination of glucose
in serum and plasma. |
| Indication(s) for Use | Intended to measure glucose in
human serum and plasma. Glu-
cose measurements are used in
the diagnosis and treatment of
carbohydrate metabolism disor-
ders including diabetes mellitus,
neonatal hypoglycemia, and idio-
pathic hypoglycemia, and of pan-
creatic islet cell carcinoma. | Intended to measure glucose in hu-
man serum and plasma. Glucose
measurements are used in the diag-
nosis and treatment of carbohydrate
metabolism disorders including dia-
betes mellitus, neonatal hypoglyce-
mia, and idiopathic hypoglycemia,
and of pancreatic islet cell carci-
noma. |
| Assay protocol | Enzymatic method using glucose
oxidase coupled with peroxidase
(Trinder method). | Enzymatic method using glucose
oxidase coupled with peroxidase
(Trinder method). |
| Composition | Reagent R:
Phosphate buffer; pH 7.4 13.8 mmol/L ;
Phenol 10 mmol/L ;
4-Aminoantipyrine 0.3 mmol/L :
Glucose oxidase ≥ 10 000 U/L :
Peroxidase ≥ 700 U/L ;
Sodium azide Total | Total |
| | Level 36.5 mg/dL CV=2.9% | Level 90.20 mg/dL CV=1.23% |
| | Level 107.4 mg/dL CV=2.5% | Level 235.44 mg/dL CV=1.12% |
| | Level 301.5 mg/dL CV=2.1% | Level 107.18 mg/dL CV=1.44% |
| | | Level 298.97 mg/dL CV=1.05% |
| Method comparison | y=0.953 x + 3.05 mg/dL
$r^2$ = 0.997
range: 17.9 to 417.2 mg/dL | y= 0.98 x + 0.72 mg/dL
$r^2$ = 0.9974 |
| Limitations | Hemoglobin: Positive bias from 250 mg/dL on low human serum.
No significant interference up to 500 mg/dL on medium human serum.
Triglycerides: Positive bias from 814 mg/dL.
Unconjugated bilirubin: Positive bias from 15 mg/dL on low human serum. Negative bias from 18 mg/dL on medium human serum.
Conjugated bilirubin: Negative bias from 8 mg/dL on low human serum and from 18 mg/dL on medium human serum.
Ascorbic acid: Negative bias from 2 mg/dL on low human serum and from 12 mg/dL on medium human serum.
Uric acid: Negative bias from 19 mg/dL on low human serum. No significant interference up to 24 mg/dL on medium human serum.
Methyldopa: Negative bias from 0.9 mg/dL on low human serum. No significant interference up to 1 mg/dL on medium human serum. | Hemoglobin: No significant influence is observed up to 460 mg/dL.
Triglycerides: No significant influence is observed up to 613 mg/dL.
Total bilirubin: No significant influence is observed up to 8.19 mg/dL.
Direct bilirubin: No significant influence is observed up to 5.63 mg/dL. |
| Calibration Frequency | 28 days | 11 days |
| On board stability | refrigerated area : 28 days | refrigerated area: 83 days |
| Calibrator | Recommended calibration material (not included):
ELITech Clinical Systems Elical 2 | Recommended calibration material (not included):
ABX Pentra Multical |
| Controls | Recommended quality control material (not included):
ELITech Clinical Systems Elitrol I (Normal control)
ELITech Clinical Systems Elitrol II (Pathologic control) | Recommended quality control material (not included):
ABX Pentra N Control (Normal control)
ABX Pentra P Control (Pathologic control) |
2
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its predicate device.
3
SECTION 5 - 510(k) Summary - ELITech Clinical Systems ELICAL 2
| Introduction | According to the requirements of 21 CFR 807.92, the following
information provides sufficient detail to understand the basis for a de-
termination of substantial equivalence. | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | The assigned 510(k) number is: K100525 | |
| Submitter | SEPPIM S.A.S. | |
| Address | Zone Industrielle, 61500 SEES, FRANCE | |
| Phone number | + 33 (0)2 33 81 21 00 | |
| Fax number | + 33 (0)2 33 28 77 51 | |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | |
| Date of Preparation | Monday, February 15th 2010 | |
| Device names | | |
| REAGENT : | ELITech Clinical Systems ELICAL 2 | |
| Trade/proprietary Name: | ELITech Clinical Systems ELICAL 2 | |
| Common or Usual Name: | Calibrator, multi-analyte mixture, "ELICAL 2" | |
| Device Class | Class II | |
| Classification name | Calibrator (21 CFR 862.1150) | |
| Product code | JIX- Calibrator, multi-analyte mixture | |
| Predicate device | Roche Diagnostics Calibrator for Automated Systems (C.f.a.s)
(K033501) | |
| Device description | ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on
human serum containing constituents to ensure optimal calibration.
ELICAL 2 is prepared exclusively from the blood of donors tested individually
and found to be negative for HbsAg and to antibodies to HCV and HIV ac-
cording to FDA-approved methods or methods in compliance with the Euro--
pean Directive 98/79/EC, Annex II, List A. | |
| Intended Use | ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Sys-
tems methods on the Vital Scientific Selectra Junior Analyzer and the Vital
Scientific Flexor Junior Analyzer. | |
4
Comparison to Predicate device
| | ELITech Clinical Systems Device
(ELICAL 2) | Predicate device
(Roche Calibrator f.a.s.) |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ELITech Clinical Systems ELICAL
2 is a multi-parametric calibrator
for in vitro diagnostic use in the
calibration of quantitative ELITech
Clinical Systems methods on the
Vital Scientific Selectra Junior
Analyzer and the Vital Scientific
Flexor Junior Analyzer. | For in vitro diagnostic use in the
calibration of quantitative Roche
methods on Roche clinical chemis-
try analysers as specified in the
value sheets. |
| Format | Lyophilized calibrator based on
human serum with constituents
added as required to obtain desired
components levels | Lyophilized calibrator based on
human serum with constituents
added as required to obtain desired
components levels |
| Level | Single level | Single level |
| Handling | Carefully open the vial, avoiding the
loss of lyophilate, and pipette in
exactly 3 mL of distilled/deionized
water. Carefully close the vial and
dissolve the contents completely by
occasional gentle swirling within 30
minutes avoiding the formation of
foam. | Carefully open one bottle, avoiding
the loss of lyophilate, and pipette in
exactly 3 mL of distilled/deionized
water. Carefully close the bottle and
dissolve the contents completely by
occasional gentle swirling within 30
minutes. Avoid the formation of
foam. |
| Traceability | Traceability information is given in
the value sheet included in the box. | Traceability of the target value is
given in the respective instruction
for use of the system reagents. |
| Stability | Lyophilized:
To store at 2-8°C and protected
from light until the expiry date
After reconstitution, the stabilities
are :
- 8 hours between 15-25 °C.
- 2 days between 2-8 °C.
- 4 weeks between -25 and -15 °C
(when frozen once) | Lyophilized:
Stable at 2-8°C up to expiration
date.
After reconstitution, the stabilities*
are :
- 8 hours at 15-25 °C.
- 2 days at 2-8 °C.
- 4 weeks at (-25)-(-15) °C (when
frozen once)
*Exception for bilirubin total & direct
as noted in package insert |
Elical 2 assigned values are the following ones:
| Components | Under review | Included in this
submission | Cleared |
|---------------|--------------|--------------------------------|---------|
| AST-GOT | | | K093883 |
| Glucose | | X | |
| Phosphorus | K100263 | | |
| Total Protein | | X | |
| Urea | K100263 | | |
| BUN | K100263 | | |
5
| A-L-A-A-A-A-A-A-A-
| Uric acıd | K100263 | ||
|---|---|---|---|
| Cholesteroi | 1 | ||
| K102993 | A PROPER OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTI | ||
| Comments of Concession of Children of | Sheep States of Corporary of Career of Carrier of Children Company of Children Company of | ||
| Triglycerides | |||
| A 80 000 000 | K102993 |
Conclusion The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
6
SECTION 5 - 510(k) Summary - ELITech Clinical Systems ELITROL I and ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Introduction | According to the requirements of 21 CFR 807.92, the following
information provides sufficient detail to understand the basis for a de-
termination of substantial equivalence. |
|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The assigned 510(k) number is: K100525 |
| Submitter | SEPPIM S.A.S. |
| Address | Zone Industrielle, 61500 SEES, FRANCE |
| Phone number | + 33 (0)2 33 81 21 00 |
| Fax number | + 33 (0)2 33 28 77 51 |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) |
| Date of Preparation | Monday, February 15th 2010 |
| Device names | |
| CONTROLS:
Trade/proprietary Name:
Common or Usual Name:
Device Class
Classification name
Product code | ELITech Clinical Systems ELITROL I and ELITROL II
Multi-analyte controls - all kinds, "ELITROL I"- "ELITROL II"
Class I
Quality control material (assayed and unassayed). (21 CFR
862.1660)
JJX- Multi-analyte controls - all kinds |
| Predicate device | Roche Diagnostics Precinorm U (K041227)
Roche Diagnostics Precipath U (K041227) |
| Device description | ELITech Clinical Systems ELITROL I and ELITROL II are two level quality
control products consisting of lyophilized human serum containing constituents
at desired levels.
Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested
individually and found to be negative for HbsAg and to antibodies to HCV and
HIV according to FDA-approved methods or methods in compliance with the
European Directive 98/79/EC, Annex II, List A. |
| Intended Use | ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in
vitro diagnostic use in accuracy control of quantitative ELITech Clinical Sys-
tems methods on the Vital Scientific Selectra Junior Analyzer and the Vital
Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL II is a multi-parametric control serum for in
vitro diagnostic use in accuracy control of quantitative ELITech Clinical Sys-
tems methods on the Vital Scientific Selectra Junior Analyzer and the Vital
Scientific Flexor Junior Analyzer. |
7
Comparison to Predicate device
| | ELITech Clinical Systems Device
ELITROL I / ELITROL II | Predicate Device
Roche Precinorm U / Precipath U |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ELITech Clinical Systems ELITROL
I is a multi-parametric control serum
for in vitro diagnostic use in accu-
racy control of quantitative ELITech
Clinical Systems methods on the
Vital Scientific Selectra Junior Ana-
lyzer and the Vital Scientific Flexor
Junior Analyzer.
ELITech Clinical Systems ELITROL
II is a multi-parametric control se-
rum for in vitro diagnostic use in
accuracy control of quantitative
ELITech Clinical Systems methods
on the Vital Scientific Selectra Jun-
ior Analyzer and the Vital Scientific
Flexor Junior Analyzer. | For in vitro diagnostic use in quality
control by monitoring accuracy and
precision for the quantitative meth-
ods as specified in the value sheet |
| Format | Lyophilized human sera with con-
stituents added as required to ob-
tain desired components levels | Lyophilized human sera with con-
stituents added as required to ob-
tain desired components levels |
| Levels | Two levels | Two levels |
| Handling | Carefully open the vial, avoiding the
loss of lyophilate, and pipette in
exactly 5 mL of distilled/deionized
water. Carefully close the vial and
dissolve the contents completely by
occasional gentle swirling within 30
minutes avoiding the formation of
foam. | Carefully open the bottle, avoiding
the loss of lyophilate, and pipette in
exactly 5 mL of distilled/deionized
water. Carefully close the bottle and
dissolve the contents completely by
occasional gentle swirling within 30
minutes. Avoid the formation of
foam. |
| Stability | Lyophilized:
To store at 2-8°C and protected
from light until the expiry date
After reconstitution, the stabilities
are :
- 12 hours between 15-25 °C. | Lyophilized:
Stable at 2-8°C up to expiration
date.
After reconstitution, the stabilities*
are :
- 12 hours at 15-25 °C. |
Elitrol I & Elitrol II assigned values are the following ones:
| Components | Under review | Included in this
submission | Cleared |
|------------|--------------|--------------------------------|---------|
| AST-GOT | | | K093883 |
| Glucose | | X | |
| Phosphorus | K100263 | | |
8
| Total Protein | X | ||
|---|---|---|---|
| Urea | K100263 | ||
| BUN | K100263 | ||
| Uric acid | K100263 | ||
| Cholesterol | K102993 | ||
| Triglycerides | K102993 |
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of these devices versus the predicate devices are not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread, symbolizing the department's mission related to health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Seppim S.A.S. c/o Debra K. Hutson ELITechGroup Epoch Biosciences 21720 2310 Dr. SE, Suite 150 Bothell, Washington 98021
DEC 1 5 20:0
Re: K100525 Trade Name: ELITech Clinical Systems Glucose PAP SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL 1 and ELITROL 2 Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, JIX, JJX Dated: December 13, 2010 Received: December 15, 2010
Dear Ms. Hutson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
10
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
Courthey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
11
Indications for Use Form
510(k) Number (if known): _K100525
Device Name:
Indications for Use:
ELITech Clinical Systems GLUCOSE PAP SL is intended for use with ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II for the quantitative in vitro diagnostic determination of glucose in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k/00.25
Page 1 of 3
12
Indications for Use Form
510(k) Number (if known): _K100525 ___________________________________________________________________________________________________________________________________________
DEC 1 5 2010
Device Name: ELITech Clinical Systems ELICAL 2______________________________________________________________________________________________________________
Indications for Use:
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ans 25
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k/00(-2)
Page Dof 3
13
Indications for Use Form
DEC 1 5 2010
510(k) Number (if known): K100525
Device Name: ELITech Clinical Systems ELITROL 1 and ELITROL 2
Indications for Use:
ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100524
Page of 3